[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610604":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":58,"overallOfficials":11,"centralContacts":68,"locations":74,"responsibleParty":96,"collaborators":11,"id":98,"slug":11,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":11,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":11,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Guangdong Hengrui Pharmaceutical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The ratio of 24-hour urine protein-creatinine ratio (24-hour UPCR) to the baseline.",null,"At Week 24.",[14,17,19,21,23,25,27,29,31,33],{"measure":15,"description":11,"timeFrame":16},"The proportion of subjects achieving complete renal response (CRR).","At Week 24 and Week 52.",{"measure":18,"description":11,"timeFrame":16},"The proportion of subjects achieving partial renal response (PRR).",{"measure":20,"description":11,"timeFrame":16},"The proportion of subjects achieving at least 50% improvement in 24-hour UPCR compared to the baseline.",{"measure":22,"description":11,"timeFrame":16},"The proportion of subjects achieving at least 25% improvement in 24-hour UPCR compared to the baseline.",{"measure":24,"description":11,"timeFrame":16},"The proportion of subjects whose 24-hour UPCR was less than 0.5 g\u002Fg.",{"measure":26,"description":11,"timeFrame":16},"The proportion of subjects whose 24-hour UPCR was less than 0.7 g\u002Fg.",{"measure":28,"description":11,"timeFrame":16},"The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 5 mg\u002Fday.",{"measure":30,"description":11,"timeFrame":16},"The proportion of subjects taking prednisone or the equivalent dose of glucocorticoids ≤ 7.5 mg\u002Fday.",{"measure":32,"description":11,"timeFrame":16},"The changes in the Chronic Disease Treatment Function Assessment - Fatigue Scale (FACIT) score relative to the baseline.",{"measure":34,"description":11,"timeFrame":35},"Adverse events (AEs).","Up to 52 weeks.",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":42},"QUADRUPLE",[43,44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[48,53],{"label":49,"type":50,"description":11,"interventionNames":51},"SHR-2173 Injection Group","EXPERIMENTAL",[52],"Drug: SHR-2173 Injection",{"label":54,"type":55,"description":11,"interventionNames":56},"SHR-2173 Injection Placebo Group","PLACEBO_COMPARATOR",[57],"Drug: SHR-2173 Injection Blank Preparation",[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":11},"DRUG","SHR-2173 Injection","SHR-2173 injection.",[49],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"SHR-2173 Injection Blank Preparation","SHR-2173 injection blank preparation.",[54],[69],{"name":70,"role":71,"phone":72,"phoneExt":11,"email":73},"Su Zhang","CONTACT","+86-0518-82342973","su.zhang.sz3@hengrui.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"The General Hospital of the Eastern Theater Command of the People's Liberation Army of China","RECRUITING","Nanjing","Jiangsu","210002","China","CN",{"type":84,"coordinates":85},"Point",[86,87],118.77778,32.06167,{"lat":87,"lon":86},[90,94],{"name":91,"role":71,"phone":92,"phoneExt":11,"email":93},"Zhihong Liu","+86-025-80862022","zhliunj@vip.163.com",{"name":91,"role":95,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":97,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610604",false,"NCT07229742","A Phase II Clinical Study on the Efficacy and Safety of SHR-2173 Injection in the Treatment of Patients With Active Lupus Nephritis","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Active Lupus Nephritis","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive) at informed consent signing, regardless of sex;\n2. Body weight ≥ 40.0 kg and body mass index (BMI) ≥ 16 kg\u002Fm² to ≤ 28 kg\u002Fm² at screening;\n3. Diagnosed with systemic lupus erythematosus (SLE) per 1997 ACR criteria or 2019 EULAR\u002FACR classification criteria;\n4. Positive antinuclear antibody (titer ≥ 1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening;\n5. Histologically confirmed active lupus nephritis (LN) class III or IV ± class V by renal biopsy, per 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) standards within 1 year preceding or during screening.\n\nExclusion Criteria:\n\n1. Received renal dialysis within 12 months preceding screening, or anticipated requirement for dialysis\u002Frenal transplantation within 6 months post-enrollment;\n2. Renal biopsy demonstrating \\> 50% globally sclerosed glomeruli;\n3. Active severe\u002Funstable neuropsychiatric SLE (NPSLE);\n4. Catastrophic antiphospholipid syndrome (APS) within 12 months pre-screening, or APS-related thrombotic events (except non-catastrophic\u002Fmild APS cases with stable anticoagulation ≥12 weeks prior to screening);\n5. Non-LN renal diseases potentially confounding disease assessment (e.g., diabetic nephropathy per investigator judgment);\n6. Inflammatory\u002Fautoimmune diseases beyond SLE\u002FLN that may interfere with efficacy\u002Fsafety interpretation.","ALL","18 Years","70 Years",{"count":108,"type":109},51,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The study is a Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with lupus nephritis (LN). It adopts a randomized, double-blind, placebo-controlled, multicenter trial design.",[115],"Active Lupus Nephritis","2025-11-28",{"date":118,"type":119},"2025-12-01","ACTUAL",{"date":121,"type":119},"2025-11-22",{"date":123,"type":109},"2028-03",{"name":5,"class":6},1]